Traceability assessment model for checking traceability requirement compliance of a medical device software development process with ISO/IEC 62304

Abstract

Medical device software must take the safety of the user into serious consideration since the failure of the medical device software can lead to hazardous situations in the user's life. The software development process could ensure the user’s safety by the software system problem resolution's traceability. The traceability should start from the beginning of the medical device software development process to the maintenance lifecycle. This demonstrates that the safe software has been built using a defined process. This document describes the ISO/IEC62304 Medical device software standard, software development lifecycle, and traceability in the process of solving problems. This approach has focused on small and medium organizations.

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